ATE413885T1 - Getrocknete blutfaktorzusammensetzung mit trehalose - Google Patents

Getrocknete blutfaktorzusammensetzung mit trehalose

Info

Publication number
ATE413885T1
ATE413885T1 AT03002147T AT03002147T ATE413885T1 AT E413885 T1 ATE413885 T1 AT E413885T1 AT 03002147 T AT03002147 T AT 03002147T AT 03002147 T AT03002147 T AT 03002147T AT E413885 T1 ATE413885 T1 AT E413885T1
Authority
AT
Austria
Prior art keywords
trehalose
blood factor
factor composition
dried blood
stable
Prior art date
Application number
AT03002147T
Other languages
English (en)
Inventor
Bruce Joseph Roser
Original Assignee
Quadrant Drug Delivery Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Quadrant Drug Delivery Ltd filed Critical Quadrant Drug Delivery Ltd
Application granted granted Critical
Publication of ATE413885T1 publication Critical patent/ATE413885T1/de

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Cell Biology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Virology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AT03002147T 1995-01-19 1996-01-19 Getrocknete blutfaktorzusammensetzung mit trehalose ATE413885T1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GBGB9501040.1A GB9501040D0 (en) 1995-01-19 1995-01-19 Dried composition

Publications (1)

Publication Number Publication Date
ATE413885T1 true ATE413885T1 (de) 2008-11-15

Family

ID=10768253

Family Applications (2)

Application Number Title Priority Date Filing Date
AT03002147T ATE413885T1 (de) 1995-01-19 1996-01-19 Getrocknete blutfaktorzusammensetzung mit trehalose
AT96900633T ATE245442T1 (de) 1995-01-19 1996-01-19 Getrocknete zubereitung von bluttfaktoren, enthaltend trehalose

Family Applications After (1)

Application Number Title Priority Date Filing Date
AT96900633T ATE245442T1 (de) 1995-01-19 1996-01-19 Getrocknete zubereitung von bluttfaktoren, enthaltend trehalose

Country Status (15)

Country Link
US (2) US6649386B2 (de)
EP (4) EP2258402A3 (de)
JP (1) JP3898221B2 (de)
KR (1) KR100417593B1 (de)
CN (1) CN1152713C (de)
AT (2) ATE413885T1 (de)
AU (1) AU704317B2 (de)
CA (2) CA2671383C (de)
DE (2) DE69629209T2 (de)
DK (2) DK1308170T3 (de)
ES (2) ES2202425T3 (de)
GB (1) GB9501040D0 (de)
PT (2) PT1308170E (de)
SI (1) SI1308170T1 (de)
WO (1) WO1996022107A1 (de)

Families Citing this family (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7253262B2 (en) * 1995-01-19 2007-08-07 Quandrant Drug Delivery Limited Dried blood factor composition comprising trehalose
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
US7244824B2 (en) * 1995-01-19 2007-07-17 Quadrant Drug Delivery Limited Dried blood factor composition comprising trehalose
US6964771B1 (en) 1995-06-07 2005-11-15 Elan Drug Delivery Limited Method for stably incorporating substances within dry, foamed glass matrices
US6632648B1 (en) * 1996-05-14 2003-10-14 Elan Drug Delivery Limited Methods of terminal sterilization of fibrinogen
GB9616536D0 (en) 1996-08-06 1996-09-25 Quadrant Holdings Cambridge Co-amoxiclav dosage form
AUPO871997A0 (en) * 1997-08-25 1997-09-18 Csl Limited Dried biologically or therapeutically active preparations
EP1820516B1 (de) 1999-02-22 2013-07-24 University of Connecticut Neue albuminfreie Faktor VIII Formulierungen
US7799765B2 (en) * 2001-08-10 2010-09-21 Kabushiki Kaisha Hayashibara Seibutsu Kagaku Kenkyujo Association compound of trehalose or maltitol with metal ion compound
US8541002B2 (en) 2003-09-12 2013-09-24 Agenus Inc. Vaccine for treatment and prevention of herpes simplex virus infection
WO2005094873A1 (en) * 2004-03-19 2005-10-13 Baxter International Inc. Factor ixa for the treatment of bleeding disorders
EP2168975A3 (de) 2004-05-24 2012-01-11 Genvault Corporation Methode zur stabilen Lagerung von Biomolekülen in wiedergewinnbarer Form
KR100624013B1 (ko) 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
US8133484B2 (en) 2006-12-15 2012-03-13 Lifebond Ltd Hemostatic materials and dressing
WO2008078189A2 (en) * 2006-12-20 2008-07-03 Bayer Healthcare Llc Factor vii and viia compositions
EP1958618A1 (de) 2007-02-15 2008-08-20 Octapharma AG Verfahren zur Gefriertrocknung mit optimierter Rekonstitution von Biopolymeren
WO2009082648A1 (en) * 2007-12-21 2009-07-02 Inspiration Biopharmaceuticals, Inc. Stabilized factor ix formulations containing trehalose
EP2244814B1 (de) * 2007-12-28 2021-06-02 Takeda Pharmaceutical Company Limited Formulierungen von rekombinantem vwf
US11197916B2 (en) 2007-12-28 2021-12-14 Takeda Pharmaceutical Company Limited Lyophilized recombinant VWF formulations
JP2012501681A (ja) 2008-09-12 2012-01-26 ジェンボールト コーポレイション 生体分子の貯蔵および安定化のためのマトリックスおよび媒体
EP2349314B1 (de) 2008-10-21 2013-02-27 Baxter International Inc. Lyophilisierte rekombinante vwf-formulierungen
EP2385825B1 (de) 2008-11-07 2018-10-10 University of Connecticut Faktor-viii-formulierungen
EP2963111A1 (de) 2009-12-22 2016-01-06 Lifebond Ltd Modifizierung von enzymatischen vernetzern zur steuerung der eigenschaften vernetzter matrizen
EP2732262A4 (de) * 2011-07-13 2014-12-10 Denator Ab Verfahren zur stabilisierung von flüssigen biologischen proben
CN102416171B (zh) * 2011-12-06 2013-12-25 中国医学科学院输血研究所 高纯度凝血酶原复合物制品干热病毒灭活过程中的保护剂
US9700486B2 (en) 2013-04-24 2017-07-11 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
EP3082769B1 (de) * 2013-12-19 2018-01-31 Janssen Vaccines & Prevention B.V. Verbesserte formulierungen für virosome
JP6516829B2 (ja) 2014-08-04 2019-05-22 シーエスエル、リミテッド 第ｖｉｉｉ因子製剤
EP3294324A1 (de) 2015-05-13 2018-03-21 Agenus Inc. Impfstoffe zur behandlung und prävention von krebs
CN107333750A (zh) * 2017-06-11 2017-11-10 成都吱吖科技有限公司 一种长时血液细胞稳定剂
EP3784688A2 (de) 2018-04-26 2021-03-03 Agenus Inc. Hitzeschockproteinbindende peptidzusammensetzungen und verfahren zu deren verwendung
US11998654B2 (en) 2018-07-12 2024-06-04 Bard Shannon Limited Securing implants and medical devices
WO2021001522A1 (en) 2019-07-04 2021-01-07 CSL Behring Lengnau AG A truncated von willebrand factor (vwf) for increasing the in vitro stability of coagulation factor viii
EP4240757A2 (de) 2020-11-09 2023-09-13 Takeda Pharmaceutical Company Limited Reinigung von fviii aus plasma mittels siliciumoxidadsorption
WO2022261716A1 (en) * 2021-06-16 2022-12-22 Exopharm Limited Aqueous formulations for preservation of extracellular vesicles
WO2024102796A2 (en) * 2022-11-08 2024-05-16 University Of Wyoming Stabilization of biologics and human blood clotting factor viii in a dry state

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4361509A (en) 1981-12-14 1982-11-30 Scripps Clinic And Research Foundation Ultrapurification of factor VIII using monoclonal antibodies
US4495175A (en) * 1982-08-05 1985-01-22 University Of Rochester Preparation of highly purified human antihemophilic factor
IL74909A (en) 1984-04-20 1992-01-15 Genentech Inc Preparation of functional human factor viii and dna sequences,expression vectors,transformed microorganisms and cell lines used therein
EP0182448A3 (de) 1984-08-24 1987-10-28 Genetics Institute, Inc. Verfahren zur Herstellung von Faktor VIII und verwandte Produkte
JPH0779694B2 (ja) * 1985-07-09 1995-08-30 カドラント バイオリソ−シズ リミテツド 蛋白質および同類品の保護
US4758657A (en) * 1985-07-11 1988-07-19 Armour Pharmaceutical Company Method of purifying Factor VIII:C
US4806343A (en) * 1986-03-13 1989-02-21 University Of Southwestern Louisiana Cryogenic protectant for proteins
CA1329760C (en) * 1987-10-29 1994-05-24 Ted C. K. Lee Plasma and recombinant protein formulations in high ionic strength media
US4877608A (en) * 1987-11-09 1989-10-31 Rorer Pharmaceutical Corporation Pharmaceutical plasma protein formulations in low ionic strength media
AU650045B2 (en) * 1990-09-12 1994-06-09 Lifecell Corporation Method and apparatus for cryopreparation dry stabilization and rehydration of biological suspensions
DE4111393A1 (de) 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
US5288853A (en) 1992-04-30 1994-02-22 Alpha Therapeutic Corporation Factor viii purification process
ATE198277T1 (de) * 1992-10-02 2001-01-15 Genetics Inst Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator
SE504074C2 (sv) * 1993-07-05 1996-11-04 Pharmacia Ab Proteinberedning för subkutan, intramuskulär eller intradermal administrering
WO1995003332A1 (en) 1993-07-23 1995-02-02 Baxter International Inc. Activated human factor viii and method of preparation
US5576291A (en) * 1993-09-13 1996-11-19 Baxter International Inc. Activated factor VIII as a therapeutic agent and method of treating factor VIII deficiency
US5955448A (en) 1994-08-19 1999-09-21 Quadrant Holdings Cambridge Limited Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
US7253262B2 (en) * 1995-01-19 2007-08-07 Quandrant Drug Delivery Limited Dried blood factor composition comprising trehalose
US5804420A (en) * 1997-04-18 1998-09-08 Bayer Corporation Preparation of recombinant Factor VIII in a protein free medium
EP1820516B1 (de) 1999-02-22 2013-07-24 University of Connecticut Neue albuminfreie Faktor VIII Formulierungen

Also Published As

Publication number Publication date
PT871476E (pt) 2003-12-31
CA2671383C (en) 2012-04-24
ATE245442T1 (de) 2003-08-15
ES2202425T3 (es) 2004-04-01
DK0871476T3 (da) 2003-11-10
SI1308170T1 (sl) 2009-04-30
EP0871476A1 (de) 1998-10-21
CN1179107A (zh) 1998-04-15
EP1308170A2 (de) 2003-05-07
AU4454096A (en) 1996-08-07
PT1308170E (pt) 2008-12-26
JP3898221B2 (ja) 2007-03-28
CA2671383A1 (en) 1996-07-25
WO1996022107A1 (en) 1996-07-25
DE69637749D1 (de) 2008-12-24
CA2210872C (en) 2009-09-08
EP0871476B1 (de) 2003-07-23
DE69629209T2 (de) 2004-02-19
KR19980701500A (ko) 1998-05-15
CN1152713C (zh) 2004-06-09
EP2258402A2 (de) 2010-12-08
EP1974741A1 (de) 2008-10-01
EP1308170A3 (de) 2004-03-03
GB9501040D0 (en) 1995-03-08
CA2210872A1 (en) 1996-07-25
EP1308170B1 (de) 2008-11-12
DE69629209D1 (de) 2003-08-28
US20020128207A1 (en) 2002-09-12
KR100417593B1 (ko) 2004-04-30
DK1308170T3 (da) 2008-12-15
AU704317B2 (en) 1999-04-22
US7803911B2 (en) 2010-09-28
US20090149388A1 (en) 2009-06-11
ES2316658T3 (es) 2009-04-16
EP2258402A3 (de) 2011-01-05
US6649386B2 (en) 2003-11-18
JPH11503719A (ja) 1999-03-30

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